Trial Outcomes & Findings for Telemedicine for PrEP Throughout Mississippi (NCT NCT03840382)

Results Overview

Number of participants who attended one or more PrEP telemedicine appointments with a UMMC PrEP specialist, in the past 3 months, extracted from patient's electronic medical record at 3 months post-intervention.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

74 participants

Primary outcome timeframe

Assessed at 3 months

Results posted on

2024-04-29

Participant Flow

Participant milestones

Participant milestones
Measure	Tele-PrEP Intervention The telemedicine intervention will allow participants to discuss HIV prevention and PrEP with PrEP specialists at an academic medical center via videoconference from their local community based organization (CBO). During the intervention, participants will gain information related to HIV and PrEP, view a video to improve motivation for engagement in PrEP related care, and receive resources to address barriers to care. Tele-PrEP Intervention: Telemedicine conferences with PrEP-specialists
Overall Study STARTED	74
Overall Study COMPLETED	63
Overall Study NOT COMPLETED	11

Reasons for withdrawal

Reasons for withdrawal
Measure	Tele-PrEP Intervention The telemedicine intervention will allow participants to discuss HIV prevention and PrEP with PrEP specialists at an academic medical center via videoconference from their local community based organization (CBO). During the intervention, participants will gain information related to HIV and PrEP, view a video to improve motivation for engagement in PrEP related care, and receive resources to address barriers to care. Tele-PrEP Intervention: Telemedicine conferences with PrEP-specialists
Overall Study Lost to Follow-up	11

Baseline Characteristics

Only those who completed 80% of the scale or more are included in the analyses. This explains why the number analyzed for this measure is lower than the overall number of baseline participants.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tele-PrEP Intervention n=63 Participants The telemedicine intervention will allow participants to discuss HIV prevention and PrEP with PrEP specialists at an academic medical center via videoconference from their local community based organization (CBO). During the intervention, participants will gain information related to HIV and PrEP, view a video to improve motivation for engagement in PrEP related care, and receive resources to address barriers to care. Tele-PrEP Intervention: Telemedicine conferences with PrEP-specialists
Age, Continuous	30.3 years STANDARD_DEVIATION 9.1 • n=63 Participants
Sex: Female, Male Female	31 Participants n=63 Participants
Sex: Female, Male Male	32 Participants n=63 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=63 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	60 Participants n=63 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=63 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=63 Participants
Race (NIH/OMB) Asian	0 Participants n=63 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=63 Participants
Race (NIH/OMB) Black or African American	51 Participants n=63 Participants
Race (NIH/OMB) White	9 Participants n=63 Participants
Race (NIH/OMB) More than one race	1 Participants n=63 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=63 Participants
PrEP knowledge	2.63 score on a scale STANDARD_DEVIATION 1.72 • n=63 Participants
Motivational readiness for PrEP and PrEP-related care	25.07 score on a scale STANDARD_DEVIATION 4.37 • n=61 Participants • Only those who completed 80% of the scale or more are included in the analyses. This explains why the number analyzed for this measure is lower than the overall number of baseline participants.

PRIMARY outcome

Timeframe: Assessed at 3 months

Number of participants who attended one or more PrEP telemedicine appointments with a UMMC PrEP specialist, in the past 3 months, extracted from patient's electronic medical record at 3 months post-intervention.

Outcome measures

Outcome measures
Measure	Tele-PrEP Intervention n=63 Participants The telemedicine intervention will allow participants to discuss HIV prevention and PrEP with PrEP specialists at an academic medical center via videoconference from their local community based organization (CBO). During the intervention, participants will gain information related to HIV and PrEP, view a video to improve motivation for engagement in PrEP related care, and receive resources to address barriers to care. Tele-PrEP Intervention: Telemedicine conferences with PrEP-specialists
Number of Participants Who Attended One or More PrEP Telemedicine Appointments at 3 Months Post-intervention (Electronic Medical Record Extraction)	8 Participants

PRIMARY outcome

Timeframe: Assessed at 6 months

Number of participants who attended one or more PrEP telemedicine appointments with a UMMC PrEP specialist, in the past 3 months, extracted from patient's electronic medical record at 6 months post-intervention.

Outcome measures

Outcome measures
Measure	Tele-PrEP Intervention n=63 Participants The telemedicine intervention will allow participants to discuss HIV prevention and PrEP with PrEP specialists at an academic medical center via videoconference from their local community based organization (CBO). During the intervention, participants will gain information related to HIV and PrEP, view a video to improve motivation for engagement in PrEP related care, and receive resources to address barriers to care. Tele-PrEP Intervention: Telemedicine conferences with PrEP-specialists
Number of Participants Who Attended One or More PrEP Telemedicine Appointments at 6 Months Post-intervention (Electronic Medical Record Extraction)	2 Participants

PRIMARY outcome

Timeframe: Assessed at 3 months

Number of participants who received a PrEP medication prescription in past 3 months, extracted from patient's electronic medical record at 3-month follow-up.

Outcome measures

Outcome measures
Measure	Tele-PrEP Intervention n=63 Participants The telemedicine intervention will allow participants to discuss HIV prevention and PrEP with PrEP specialists at an academic medical center via videoconference from their local community based organization (CBO). During the intervention, participants will gain information related to HIV and PrEP, view a video to improve motivation for engagement in PrEP related care, and receive resources to address barriers to care. Tele-PrEP Intervention: Telemedicine conferences with PrEP-specialists
Number of Participants Who Received a PrEP Medication Prescription at 3 Months (Electronic Medical Record Extraction)	22 Participants

PRIMARY outcome

Timeframe: Assessed at 6 months

Number of participants who received a PrEP medication prescription in past 3 months, extracted from patient's electronic medical record at 6-month follow-up.

Outcome measures

Outcome measures
Measure	Tele-PrEP Intervention n=63 Participants The telemedicine intervention will allow participants to discuss HIV prevention and PrEP with PrEP specialists at an academic medical center via videoconference from their local community based organization (CBO). During the intervention, participants will gain information related to HIV and PrEP, view a video to improve motivation for engagement in PrEP related care, and receive resources to address barriers to care. Tele-PrEP Intervention: Telemedicine conferences with PrEP-specialists
Number of Participants Who Received a PrEP Medication Prescription at 6 Months (Electronic Medical Record Extraction)	17 Participants

PRIMARY outcome

Timeframe: Assessed at 3 months and 6 months

Population: Only participants who self-reported current PrEP use were included in these analyses.

Self-reported number of days a PrEP dose was missed in the past 30 days. Ranging from 0 to 30.

Outcome measures

Outcome measures
Measure	Tele-PrEP Intervention n=28 Participants The telemedicine intervention will allow participants to discuss HIV prevention and PrEP with PrEP specialists at an academic medical center via videoconference from their local community based organization (CBO). During the intervention, participants will gain information related to HIV and PrEP, view a video to improve motivation for engagement in PrEP related care, and receive resources to address barriers to care. Tele-PrEP Intervention: Telemedicine conferences with PrEP-specialists
Adherence to PrEP (Self-report) Missed Doses at 3-Months	2.07 missed PrEP doses Standard Deviation 3.03
Adherence to PrEP (Self-report) Missed Doses at 6-Months	18.75 missed PrEP doses Standard Deviation 13.50

PRIMARY outcome

Timeframe: Assessed at 3 months

Number of participants with 0-2 PrEP medication refills in past 3 months (extracted from electronic medical record at 3-month follow-up).

Outcome measures

Outcome measures
Measure	Tele-PrEP Intervention n=63 Participants The telemedicine intervention will allow participants to discuss HIV prevention and PrEP with PrEP specialists at an academic medical center via videoconference from their local community based organization (CBO). During the intervention, participants will gain information related to HIV and PrEP, view a video to improve motivation for engagement in PrEP related care, and receive resources to address barriers to care. Tele-PrEP Intervention: Telemedicine conferences with PrEP-specialists
Number of Participants With 0-2 PrEP Refills at 3 Months (Electronic Medical Record ) 2 Refills	9 Participants
Number of Participants With 0-2 PrEP Refills at 3 Months (Electronic Medical Record ) 0 Refills	43 Participants
Number of Participants With 0-2 PrEP Refills at 3 Months (Electronic Medical Record ) 1 Refill	11 Participants

PRIMARY outcome

Timeframe: Assessed at 6 months

Number of Participants With 0-2 PrEP Refills in past 3 months (extracted from electronic medical record at 6-month follow-up).

Outcome measures

Outcome measures
Measure	Tele-PrEP Intervention n=63 Participants The telemedicine intervention will allow participants to discuss HIV prevention and PrEP with PrEP specialists at an academic medical center via videoconference from their local community based organization (CBO). During the intervention, participants will gain information related to HIV and PrEP, view a video to improve motivation for engagement in PrEP related care, and receive resources to address barriers to care. Tele-PrEP Intervention: Telemedicine conferences with PrEP-specialists
Number of Participants With 0-2 PrEP Refills at 6 Months (Electronic Medical Record) 0 Refills	46 Participants
Number of Participants With 0-2 PrEP Refills at 6 Months (Electronic Medical Record) 1 Refill	12 Participants
Number of Participants With 0-2 PrEP Refills at 6 Months (Electronic Medical Record) 2 Refills	5 Participants

SECONDARY outcome

Timeframe: Assessed at 3 months and 6 months

Population: Only those who completed 80% of the scale or more are included in the analyses. This is why only 57 and 54 participants were included in the 3-month and 6-month analysis, respectively.

This 5-item measure was used to assess knowledge (true/false/don't know) based on facts from the CDC and the San Francisco AIDS Foundation websites concerning PrEP. Scores for the measure could range from 0 to 5 with higher scores indicating greater PrEP knowledge.

Outcome measures

Outcome measures
Measure	Tele-PrEP Intervention n=63 Participants The telemedicine intervention will allow participants to discuss HIV prevention and PrEP with PrEP specialists at an academic medical center via videoconference from their local community based organization (CBO). During the intervention, participants will gain information related to HIV and PrEP, view a video to improve motivation for engagement in PrEP related care, and receive resources to address barriers to care. Tele-PrEP Intervention: Telemedicine conferences with PrEP-specialists
PrEP Knowledge Score at 3-months	2.89 score on a scale Standard Deviation 1.84
PrEP Knowledge Score at 6-months	2.93 score on a scale Standard Deviation 1.64

SECONDARY outcome

Timeframe: Assessed at 3 months and 6 months

Population: Only those who completed 80% of the scale or more are included in the analyses. This is why only 57 and 54 participants were included in the 3-month and 6-month analysis, respectively.

This measure was a subscale adapted from The LifeWindows Information Motivation Behavioral Skills ART Adherence Questionnaire (LW-IMB-AAQ), 2006. The motivational readiness to engage in PrEP care subscale consisted of eight items with 4-point Likert responses. The possible score range for this subscale is 8 to 32, with higher scores indicating higher motivation to engage in PrEP care.

Outcome measures

Outcome measures
Measure	Tele-PrEP Intervention n=63 Participants The telemedicine intervention will allow participants to discuss HIV prevention and PrEP with PrEP specialists at an academic medical center via videoconference from their local community based organization (CBO). During the intervention, participants will gain information related to HIV and PrEP, view a video to improve motivation for engagement in PrEP related care, and receive resources to address barriers to care. Tele-PrEP Intervention: Telemedicine conferences with PrEP-specialists
Motivational Readiness for PrEP and PrEP-related Care Score at 3-Months	25.95 score on a scale Standard Deviation 4.69
Motivational Readiness for PrEP and PrEP-related Care Score at 6-Months	26.50 score on a scale Standard Deviation 4.11

SECONDARY outcome

Timeframe: Assessed at 3 months and 6 months

Population: Only those who attended a telemedicine for PrEP appointment and completed this measure on the survey were included in the analyses. By 3-month follow-up, 11 of 63 participants used telemedicine for PrEP care. By 6-month follow-up, 1 additional participant used telemedicine for PrEP care. This explains why the overall number of participants analyzed for this measure was 12, as opposed to 63.

Patients' perspective on the acceptability of using telemedicine for PrEP care was assessed with a modified version of the Client Satisfaction Questionnaire (CSQ-8). This measure was only given to participants who attended a PrEP-related telemedicine appointment. Scores for this measure could range from 2 to 8, with higher scores indicating greater satisfaction.

Outcome measures

Outcome measures
Measure	Tele-PrEP Intervention n=12 Participants The telemedicine intervention will allow participants to discuss HIV prevention and PrEP with PrEP specialists at an academic medical center via videoconference from their local community based organization (CBO). During the intervention, participants will gain information related to HIV and PrEP, view a video to improve motivation for engagement in PrEP related care, and receive resources to address barriers to care. Tele-PrEP Intervention: Telemedicine conferences with PrEP-specialists
Patient Acceptability Score Regarding the Use of Telemedicine for PrEP Care (CSQ-8) Score at 3-Months	7.27 score on a scale Standard Deviation 1.27
Patient Acceptability Score Regarding the Use of Telemedicine for PrEP Care (CSQ-8) Score at 6-Months	7.50 score on a scale Standard Deviation 1.00

Adverse Events

Tele-PrEP Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Larry Brown

Rhode Island Hospital

Phone: +1 (401) 793-8808

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place